MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. ENTERPRISE 5000

Model Number E5X1DD1CON3635C

Device Problems Collapse (1099); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation which includes an inspection of the bed is currently ongoing.Additional information will be provided upon conclusion of the investigator.

Event Description

Initially, it has been claimed that the event occurred at the time of device's delivery to the facility, after unpacking the bed and taking it up to the ward.The bed was raised to the height which allowed easier maneuvering.Then the bed's deck slightly twist and then dropped with a loud noise.Upon inspection the rear radius arm retaining "c" clip was missing.At the time of even the patient was not using the device.There were no injuries sustained.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for enterprise bed range (including model 5000x, 8000x and 9000x), we have found four cases with a similar fault description compared to the one investigated here: bed collapsed.Based on the collected information and provided desperation of the event it has been established that the bed collapsed as the radius arm detached from the sub-frame.Initial inspection conducted by an arjohuntleigh representative at the customer side revealed that the c-clip was missing.The technician had a spare "c" clip, refitted it to the bed's frame and rectified the issue.The bed has been tested and left in use at the facility.Later on it was returned to the manufacturer to conduct further evaluation of the device - performed inspection has not revealed any anomalies with the product.The c-clip is assembled by the trained operator in accordance to the relevant work instruction which indicate that during the assembly of the radius arm on the sub-frame, retaining clip (c-clip) is there in order to secure the parts.Additionally, during the final inspection of the device, conducted in accordance to the quality instruction, the gap between sub-frame and profile in radius arm is checked with use of gauge.If the retaining clip would have not been assembled the device would not pass the test and would not be released for dispatch.The device history record of bed involved in the event confirm that the c-clip was installed on the device when it was cleared for dispatch.It is also worth noting that the enterprise 5000x bed has been designed, produced and certified to meet the requirements of standard en 60601-2-52.The enterprise 5000x beds are passing the requirements of clauses: 201.9.4.2.3 - instability from horizontal and vertical forces, 201.9.8.3.1 - safe working load, 201.9.8.3.2 - static forces due to loading from persons or 201.9.8.3.3.1 dynamic forces due to sitting down.This confirms that the beds are stable devices which are not falling apart during usage.Please refer to test reports.Based on the information collected above it seems that in the claimed event the retaining clip get lost during the shipment or unpacking of the device.We have been able to clarify that the packaging of the bed was not damaged, and that the retaining clip was not found in the bed's packaging or in the area where bed collapse.The clip is also being checked in order to confirm that the chemical composition of this part is a correct one.Unfortunately, so far, we have been not able determine the exact cause of the event.In summary, the device was not being used for patient treatment/diagnosis, it failed to meet its specifications (bed collapsed) and therefore play a role in this event.Fortunately, there was no patient involvement and there were no injuries sustained.Given the circumstances and the number of products in the market we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: ENTERPRISE 5000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 62052 ; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 62052 ; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore ; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5015518
• MDR Text Key: 24810103
• Report Number: 3007420694-2015-00156
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Followup
• Report Date: 11/03/2015,07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: E5X1DD1CON3635C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2015
• Distributor Facility Aware Date: 07/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1